NCT05769088

Brief Summary

The investigation will be conducted as a double blinded, randomized, parallel between treatment conditions comparison design with two different groups ingesting a different supplement each one.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

February 20, 2023

Last Update Submit

March 2, 2023

Conditions

Keywords

FatigueSupplementProteinResistance TrainingPre-workoutStrengthRate of Perceived ExertionMuscle

Outcome Measures

Primary Outcomes (7)

  • Tensiomyography

    A TMG portable device (TMG Measurement System, 146 TMG-BMC Ltd., Ljubljana, Slovenia) with a maximal stimulation output of 110 mA·ms-1 IS used to evaluate the contractile properties of the Anterior Deltoid (AD) of the dominant limb. Changes in the evoked muscular contractile properties are estimated by analysing maximal radial displacement of the muscle belly in millimetres (Dm).

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Vertical Jump

    Height (measured in centimetres)

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Chest Medicine Ball Throw

    Medicine Ball Throw (measured in meters and centimetres).

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Maximal Mid-Thigh Pull Isometric Strength

    Maximal Strength (measured in kilograms).

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Muscle Thickness

    Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Self Perceived Energy Feeling

    All participants will fill a short questionnaire (from 1 to 5 points) about their perception of energy before every training. Energy Feeling will be assessed (Evergy level, Fatigue Level, Feeling of Alertness, and Feeling of Focus for the task, valued from 1 = low energy to 5 = high energy).

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Whole Body Perceptual Response during Resistance Training

    Self Rate of Perceived Exertion (RPE) will be assessed via OMNI RES Scale (0-10 values) during resistance training (after every circuit) and 15-20 minutes after finishing each session.

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

Secondary Outcomes (1)

  • White Blood Cells count

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

Study Arms (2)

Multi-Ingredient Pre-Workout Supplement

EXPERIMENTAL

A 60 g dose of a commercially available preworkout supplement providing 159 kcal including carbohydrates 15 g, essential amino acids 12 g, citrulline 3.5 g, Arginine, 3.5 g Taurine 1 g, L-Tyrosine 1 g, yerba mate 0.3 g and caffeine 0.4 g. With 350 ml of water.

Dietary Supplement: Ingestion of a Pre-Workout Supplement

Maltodextrin Supplement

PLACEBO COMPARATOR

A isoenergetic Maltodextrin supplement will be administered as placebo. With 350 ml of water.

Dietary Supplement: Ingestion of a Maltodextrin Supplement

Interventions

The Multi-Ingredient Pre-Workout Supplement is administered 15 minutes before the beginning of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2.5 to 5 kg are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.

Multi-Ingredient Pre-Workout Supplement

The Maltodextrin Supplement is administered 15 minutes before the beginning of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2.5 to 5 kg are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.

Maltodextrin Supplement

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy (no injuries, illnesses or medication intake).
  • Between 45 and 65 years old.
  • Active and familiarised with Resistance Training.

You may not qualify if:

  • Unhealthy (illnesses or medication intake) or injured.
  • Untrained.
  • Young (\<45 y.o.) or elderly (\>65 y.o.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT

London, Avery Hill, London., SE9 2BT, United Kingdom

Location

Related Publications (1)

  • Puente-Fernandez J, Larumbe-Zabala E, Roberts J, Naclerio F. Effect of a Multi-Ingredient Post-Workout Dietary Supplement on Body Composition and Muscle Strength - A Randomized Controlled Trial. J Diet Suppl. 2025;22(3):445-462. doi: 10.1080/19390211.2025.2488811. Epub 2025 Apr 12.

MeSH Terms

Conditions

Protein DeficiencyHypersensitivityFatigueMuscular Atrophy

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 6 Weeks of resistance training (alternate days), with a Pre-workout or Maltodextrin intake.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 15, 2023

Study Start

March 15, 2023

Primary Completion

May 15, 2023

Study Completion

May 30, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations